10 September 2020

COCIR welcomes the inception impact assessment by the European Commission on ethical and legal requirements for Artificial Intelligence (AI) and the opportunity to provide feedback. Continuing our engagement in this area, and following the earlier consultation on the AI White Paper, COCIR is pleased to share its experience and expertise on the use of AI within healthcare.

COCIR and its members have recently published a comprehensive in-depth analysis of Artificial Intelligence in Medical Device Legislation. The document provides a thorough analysis of the legal requirements applicable to AI-based medical devices.

Based on this analysis COCIR sees no need for novel regulatory frameworks for AI-based medical devices, because the requirements of the EU Medical Device Regulation4 (MDR) in combination with provisions of the General Data Protection Regulation (GDPR) are adequate to ensure excellence and trust in AI in line with European values.

COCIR looks forward to working with the EU institutions and relevant stakeholders to create the right environment for further uptake and deployment of AI in healthcare for the benefit of the patients and society, while safeguarding fundamental rights and providing the best possible care and protection.